盐酸奈法唑酮片治疗抑郁症的Ⅱ期临床研究  

The Second Phase Clinical Trials for Nefazodone to Treat Major Depressive Disorder

作　　者：白燕[1] 王继才[1] 许秀峰[1] 

机构地区：[1]昆明医学院第一附属医院精神科,昆明650032

出　　处：《昆明医学院学报》2004年第4期87-91,共5页Journal of Kunming Medical College

基　　金：湖北爱百科药业有限公司提供资助

摘　　要：目的 :评价盐酸奈法唑酮治疗抑郁症的临床疗效和安全性 .方法 :对符合《CCMD - 3》抑郁症诊断标准的 5 2例抑郁症患者进行奈法唑酮和氟西汀的对照研究 ,其中奈法唑酮组 2 6例 (30 0～ 5 0 0mg/d) ,氟西汀组 2 6例 (2 0～ 4 0mg/d) ,共治疗 6周 .采用汉密尔顿抑郁量表 (HAMD ) ,汉密尔顿焦虑量表(HAMA) ,临床总体评定量表 (CGI)评定临床疗效 ,副反应量表 (Tess)评定不良反应 .结果 :经 6周治疗后 ,奈法唑酮组治疗总有效率为 85 38% ,氟西汀组为 85 38% ,两组相比较 ,差异无显著性 (P >0 0 5 ) .两组的HAMD ,HAMA评分治疗前后相比较差异有高度显著性 (P <0 0 1) ,两组的HAMD ,HAMA评分之间比较差异无显著性 (P >0 0 5 ) .不良反应分析 ,两组药物不良反应的发生率无显著性差异 (P >0 0 5 ) ,常见的不良反应有头昏、恶心、呕吐、口干、嗜睡、食欲减退或厌食等 .结论 :奈法唑酮治疗抑郁症疗效好 ,不良反应少而轻 ,适合临床应用 .Objective: To determine the efficacy and safety of nefazodone to the depressive patients. Methods: A controlled study was carried out between 52 patients who met the CCMD-3 criteria of major depression and depressed episode. The 26 of total patients were treated with nefazodone(300～500mg/d)and the others were treated with fluoxetine (20～40mg/d)for 6 weeks. The efficacy was assessed with Hamilton Depression Rating Scale(HAMD), Hamilton Anxiety Scale(HAMA) and Clinical Global Impression (CGI) and the safety was assessed with Treatment Emergent Symptom Scale (Tess). Results: After 6 weeks treatment, the improvement rate of nefazodone group and fluoxetine group were 85.38% and 85.38% respectively (P>0.05). The scores of HAMD and HAMA in 2 groups had statistical difference before and after treatment (P<0.01; however, there was no difference between 2 groups (P>0.05). The main adverse events of 2 groups were dizziness, mouth dry, somnolence, anorexia, retching and vomiting etc. There was no significant difference in incidence of adverse events between nefazodone group and fluoxetine group. Conclusion: nefazodone is an effective antidepressants with less side effects, better safety, to fit in with clinical use.

关 键 词：治疗 盐酸奈法唑酮 不良反应 抑郁症 HAMA HAMD 氟西汀 食欲减退 显著性差异 高度 

分 类 号：R749[医药卫生—神经病学与精神病学] R743[医药卫生—临床医学]